Vaginal pessary

ABSTRACT

An adjustable vaginal pessary ( 2 ) comprising a body ( 4 ) with an outer periphery, and an inner periphery defining an aperture ( 10 ). The pessary further comprises at least one adjustable portion ( 12,13 ) located on the body between said inner and outer peripheries. The adjustable portion is bounded by two ends ( 12   a,    12   b,    13   a,    13   b ) of the body interfacing therewith. The adjustable portion is adapted to vary the distance between the two ends in the direction along the body&#39;s perimeter, thereby adjusting the length of the peripheries.

FIELD OF THE INVENTION

This invention relates to vaginal pessaries used for treating pelvicgenital organ prolapse and female urinary distress, including stressincontinence.

BACKGROUND OF THE INVENTION

Vaginal pessaries are suppositories that provide support to the vaginalwalls and are intended to treat pelvic genital organ prolapse andurinary distress in women, including stress incontinence. Such pessariesvary in size and an appropriate size is typically chosen and fitted by adoctor according to an individual patient's anatomy.

U.S. Pat. No. 4,823,814 discloses a flexible ring-shaped pessary made ofa specific material enabling the ring's shape can be deformed by handand the ring's circumference can be increased or decreased to someextent to suit various types and stages of prolapse.

U.S. Pat. No. 5,007,894 discloses a device for treating femaleincontinence comprising an annular body, which is fully inflated when itis positioned within the vagina to counteract prolapse and preventincontinence but which may also be deflated to facilitate insertion orremoval of the device.

SUMMARY OF THE INVENTION

The present invention suggests a vaginal pessary whose perimeter can beadjusted to suit a variety of women and can be easily inserted by thewoman herself, thereby eliminating the necessity of a medicalexamination to determine an appropriate pessary size or the aid of atrained health professional to perform its insertion. The adjustablevaginal pessary according to the present invention comprises a body withan outer periphery and an inner periphery defining an aperture, and anadjustable portion located on said body between said inner and outerperipheries and being bounded by two ends of said body interfacingtherewith, said portion being adapted to vary the distance between saidtwo ends in the direction along the body's perimeter, thereby adjustingthe length of said peripheries.

The adjustable vaginal pessary according to the present invention isparticularly useful in the treatment of pelvic genital organ prolapseand female urinary distress, including stress incontinence, and therebyalso the ill-effects that arise therefrom. Since its size can beadjusted, the adjustable pessary of the present invention can replace alarge majority of the range of currently produced pessary sizes, andbecause it does not utilize complicated adjusting mechanisms, thepessary of the present invention requires little time and effort toinsert and fit into the vagina as well as remove therefrom. The latteradvantage of the present invention allows a user to insert, remove, andfit the pessary herself, thereby eliminating the need for the repeatedassistance of a doctor or other such skilled health professional and,with it, the inconvenience and embarrassment which often accompany thereceipt of such assistance. In addition, in many cases, there is theadded benefit of a more sensitive and comfortable insertion and removalsince this can be performed by the user herself.

The pessary of the present invention may be adjusted to the user's sizebefore insertion into the vagina, or after the pessary is positioned inthe desired functional location within the vagina. The size of thepessary can also be reduced to facilitate its insertion. Also, theability of the pessary of the present invention to vary its size affordsconvenience to the user as it can be easily adjusted to provide varyingdegrees of support to suit the user's expected activities. In addition,the pessary of the present invention is able to accommodate a change ina user's anatomical or medical situation requiring the need for adifferent size.

The pessary of the present invention is suitable for women of all ages,and is especially suitable for women who are non-candidates for surgery.Also, due to its many advantages, the pessary of the present inventionconstitutes a more attractive alternative to surgery than currentlyavailable non-adjusting pessaries.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carriedout in practice, a preferred embodiment will now be described, by way ofnon-limiting example only, with reference to the accompanying drawings,in which:

FIG. 1A shows a pessary according to the present invention in aretracted position;

FIG. 1B shows a pessary according to the present invention in anextended position;

FIG. 2A shows an alternative embodiment for a pessary according to thepresent invention in a retracted position;

FIG. 2B shows an alternative embodiment for a pessary according to thepresent invention in an extended position.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1A schematically shows an adjustable vaginal pessary 2 according tothe present invention, which is to be inserted into a vagina to providesupport therein. The pessary 2 is annular and comprises a body 4 with anouter periphery 6 and an inner periphery 8 defining an aperture 10.While rounded shapes are preferable, the pessary 2 may have any closedgeometry so long as it contains the aperture 10.

The body 4 further comprises two adjustable portions 12 and 13 bothlocated between the inner and outer peripheries 6 and 8. The adjustableportion 12 is bounded by two ends 12 a and 12 b of the body 4 thatinterface therewith. Likewise, on the diametrically opposed side of thebody 4, the adjustable portion 13 is bounded by two interfacing ends 13a and 13 b. Each adjustable portion 12, 13 is inflatable and is adaptedto vary the distance between its two ends 12 a, 12 b, and 13 a, 13 b inthe direction of the circumference of the body 4. Being of a foldableaccordion-like shape, the adjustable portions 12 and 13 are able toexpand in the direction along the body's perimeter when inflated. Inthis way, the length of the peripheries 6 and 8 may be adjusted. Itshould be noted that the pessary 2 may include a single adjustableportion or a plurality thereof and the adjustable portions may belocated anywhere on the perimeter of the body 4.

The pessary 2 also includes a conduit 14 in communication with theadjustable portions 12 and 13 for conducting a fluid, which may be aliquid or a gas, thereto. The conduit 14 is adapted to furthercommunicate with an inflation tube 16, which supplies the conduit 14with the fluid. The inflation tube 16 includes a valve to allow a fluidto enter but prevents its spontaneous escape. The valve may also includea means available to the user permitting instant or gradual deflation ofthe portions 12 and 13. The tube 16 may be integral and therefore remainattached at all times to the conduit 14, or it may have means orconnecting and disconnecting from the conduit 14 when required forinflation and deflation.

FIG. 1A shows the pessary 2 in its retracted position where it has aminimal circumference. In operation, before or after the pessary 2 isinserted into the vagina, fluid is supplied to the adjustable portions12 and 13 via the inflation tube 16 and the conduit 14 causing thesepotions 12 and 13, and consequently the circumference of the body 4, tolengthen. FIG. 1B shows the pessary 2 in an extended position with theportions 12 and 13 filled to a certain extent. Fluid continues to beconducted to the portions 12 and 13 until the pessary 2 enlarges to adesired size. The pessary 2 is similarly reduced in size by deflation,in which fluid is removed from the adjustable portions 12 and 13 via theconduit 14.

The adjustable potions 12 and 13 may have any design or shape allowingfor the adjustment of the pessary's perimeter. The portions 12 and 13may be adapted to be fill with fluid throughout the internal space theydefine, or rather may be adapted to fill only at their walls. Thevariation of length of the portions 12 and 13 may be achieved by usingpneumatic or hydraulic methods as described above, or by any othermethod such as mechanical means.

FIGS. 2A and 2B show a pessary 2 in a retracted and extended positionrespectively having adjustable portions 22 and 23 that functionmechanically to reduce or augment the pessary's perimeter. The portions22 and 23 are based on a ratchet mechanism 24 a, 24 b having teethenabling gradual adjustment of the pessary's size. The pessary 2 mayfurther comprise a reinforcing sleeves 26 a and 26 b which addstructural support to the indented adjustable portions 22 and 23, butalso serve to provide a smoother surface and to protect the user fromcontacting the surface of the ratchet mechanism 24 a, 24 b.

Other possible mechanical alternatives for the adjustable potions mayinclude engaging, telescoping parts that slide into one another allowingfor length adjustment. Such telescoping mechanisms may include partsthat slide within each other or slide in and out of the body 4 of thepessary 2 thereby allowing its size adjustment.

The pessary 2 according to the present invention and its parts may bemade of any material that is not harmful to human use. These preferablyinclude materials that do not easily degrade or cause irritation,including medically approved grades of silicone or plastic such aspolyethylene and polyvinyl chloride.

It should be understood that the above-described embodiments are onlyexamples of an adjustable vaginal pessary and that the scope of thepresent invention fully encompasses other embodiments, which may becomeobvious to those skilled in the art. For example, the pessary may beused to provide support in the treatment of other medical conditionswhere size variance and adjustment may be useful.

1. An adjustable vaginal pessary comprising a body with an outer periphery and an inner periphery defining an aperture, and at least one adjustable portion located on said body between said inner and outer peripheries and being bounded by two ends of said body interfacing therewith, said portion being adapted to vary the distance between said two ends in the direction along the body's perimeter, thereby adjusting the length of said peripheries.
 2. An adjustable vaginal pessary according to claim 1, having a plurality of adjustable portions.
 3. An adjustable vaginal pessary according to claim 1, adapted for use in treating pelvic organ prolapse.
 4. An adjustable vaginal pessary according to claim 1, adapted for use in treating stress incontinence.
 5. An adjustable vaginal pessary according to claim 1, wherein the body has a rounded geometry.
 6. An adjustable vaginal pessary according to claim 5, wherein the geometry is annular.
 7. An adjustable vaginal pessary according to claim 1, wherein the adjustable portion comprises pneumatic means for adjusting in size.
 8. An adjustable vaginal pessary according to claim 1, wherein the adjustable portion comprises hydraulic means for adjusting in size.
 9. An adjustable vaginal pessary according to claim 7 or 8, wherein the adjustable portion has a foldable, accordion-like shape.
 10. An adjustable vaginal pessary according to claim 1, wherein the adjustable portion comprises mechanical means for adjusting in size.
 11. An adjustable vaginal pessary according to claim 9, wherein the mechanical means is a ratchet mechanism.
 12. An adjustable vaginal pessary according to claim 9, wherein the mechanical means is a telescoping mechanism.
 13. An adjustable vaginal pessary according to claim 1 substantially as described hereinbefore and illustrated in the accompanying drawings. 